Kabiven G19%

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Glucose monohydrate 20.9% equivalent to 19% glucose anhydrous;  ;  ;  ; Alanine 1.6%;  ;  ;  ; Arginine 1.13%;  ;  ;  ;  ; Aspartic acid 0.34%;  ;  ;  ;  ;  ; Calcium chloride dihydrate 0.074%;  ; Glutamic acid 0.56%;  ;  ;  ;  ;  ; Glycine 0.79%;  ;  ;  ;  ;  ; Histidine 0.68%;  ;  ;  ;  ; Isoleucine 0.56%;  ;  ;  ;  ;  ; Leucine 0.79%;  ;  ;  ;  ;  ; Lysine hydrochloride 0.9%;  ;  ;  ;  ;  ;  ; Magnesium sulfate heptahydrate 0.16%;  ;  ; Methionine 0.56%;  ;  ;  ;  ;  ; Phenylalanine 0.79%;  ;  ;  ;  ;  ; Potassium chloride 0.597%;  ; Proline 0.68%;  ; Serine 0.45%;  ;  ;  ;  ; Sodium acetate trihydrate 0.49%;  ;  ; Sodium glycerophosphate 0.54%;  ;  ;  ; Threonine 0.56%;  ;  ;  ; Tryptophan 0.19%;  ;  ;  ; Tyrosine 0.023%;  ;  ;  ; Valine 0.73%;  ;  ;  ;  ; Soya oil 20%

Available from:

Fresenius Kabi New Zealand Limited

INN (International Name):

Glucose monohydrate 20.9% (equivalent to 19% glucose anhydrous)

Pharmaceutical form:

Emulsion for injection

Composition:

Active: Glucose monohydrate 20.9% equivalent to 19% glucose anhydrous       Excipient: Water for injection Active: Alanine 1.6%       Arginine 1.13%         Aspartic acid 0.34%           Calcium chloride dihydrate 0.074%   Glutamic acid 0.56%           Glycine 0.79%           Histidine 0.68%         Isoleucine 0.56%           Leucine 0.79%           Lysine hydrochloride 0.9%             Magnesium sulfate heptahydrate 0.16%     Methionine 0.56%           Phenylalanine 0.79%           Potassium chloride 0.597%   Proline 0.68%   Serine 0.45%         Sodium acetate trihydrate 0.49%     Sodium glycerophosphate 0.54%       Threonine 0.56%       Tryptophan 0.19%       Tyrosine 0.023%       Valine 0.73%         Excipient: Glacial acetic acid Water for injection Active: Soya oil 20% Excipient: Egg lecithin Glycerol Sodium hydroxide Water for injection

Units in package:

Bag, plastic, Biofine, 1026 mL

Class:

General sale

Prescription type:

General sale

Manufactured by:

Roquette Freres

Therapeutic indications:

Parenteral nutrition for adult patients and children above 2 years of age when oral or enteral nutrition is impossible or insufficient or contraindicated.

Product summary:

Package - Contents - Shelf Life: Bag, plastic, Excel/Biofine - 1026 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel/Biofine - 1540 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel/Biofine - 2053 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel/Biofine - 2566 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel/Biofine, 4 x 1026mL - 4104 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel, 2 x 2053mL - 4106 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel, 2 x 2566mL - 5132 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Excel/Biofine, 4 x 1540mL - 6160 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Biofine, 3 x 2566mL - 7698 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C - Bag, plastic, Biofine, 4 x 2053mL - 8212 mL - 24 months from date of manufacture stored at or below 25°C 48 hours opened stored at or below 25°C

Authorization date:

2001-11-23

Patient Information leaflet

March, 2010
CMI FOR KABIVEN
Filename: KabCMI160310-clean
Page 1 of 3
Changes:New sponsor name + NZ details
KABIVEN
® G11% AND G19%
G11% contains 2.4% amino acids, 3.5% triglycerides, 6.8% glucose and
0.7% electrolytes.
G19% contains 3.3% amino acids, 3.9% triglycerides, 9.7% glucose and
0.7% electrolytes
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Kabiven. It does not contain all
the
available
information.
It
does
not
take
the
place
of
talking
to
your
doctor
or
pharmacist. All medicines have
risks and benefits. Your doctor
has
weighed
the
risks
of
you
given
Kabiven
against
any
benefits they expect it will have
for you.
PLEASE
READ
THIS
LEAFLET
CAREFULLY.
IF
YOU
HAVE
ANY
QUESTIONS OR ARE UNSURE ABOUT
ANYTHING,
PLEASE
ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE. YOU MAY NEED TO
READ IT AGAIN.
WHAT IS KABIVEN USED
FOR AND HOW DOES IT
WORK
Kabiven
is
a
sterile
emulsion
which provides your body with
nutrition
by
the
intravenous
route.
When
the
intake
of
nutrients or food into the mouth
or
directly
into
the
gut
is
not
possible, or it is not enough to
supply the body’s needs, then
intravenous
nutrients
or
foods
can be given. This is especially
important
for
people
whose
bodies are under physical stress
from illness or recent surgery.
During
illness
or
after
surgery
the
body
requires
nutrition
or
food.
Kabiven
G19%
contains
3.3%
amino acids, 3.9% triglycerides
(soya
oil),
9.7%
glucose
and
0.7% electrolytes while Kabiven
G11%
contains
2.4%
amino
acids, 3.5% triglycerides, 6.8%
glucose and 0.7% electrolytes.
Kabiven
is
usually
given
together with trace elements and
vitamins to provide a complete
intravenous diet.
BEFORE YOU ARE GIVEN
KABIVEN
You
should
NOT
be
given
Kabiven if
•
You
have
had
an
allergic reaction to egg-
yolk
containing
foods,
peanut or soy products.
•
You have an allergy to
any
of
the
ingredients
contained in Kabiven as
listed at the end of this
leaflet.
•
You have an inability to
break down fats
•
You have an inabi

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 13
1
PRODUCT NAME
KABIVEN® G19%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
KABIVEN is a three chamber bag of amino acid solution with
electrolytes, glucose solution and lipid
emulsion for intravenous infusion.
The active ingredients are:
AMINO ACIDS 3.3%: alanine (CAS No. 56-41-7), arginine (CAS No.
74-79-3), aspartic acid (CAS No.
6899-03-2), glutamic acid (CAS No. 56-86-0), glycine (CAS No.
56-40-6), histidine (CAS No. 71-00-1),
isoleucine (CAS No. 73-32-5), leucine (CAS No. 61-90-5), lysine
hydrochloride (CAS No. 657-27-2),
methionine (CAS No. 63-68-3), phenylalanine (CAS No. 63-91-2), proline
(CAS No. 147-85-3), serine
(CAS No. 56-45-1), threonine (CAS No. 72-19-5), tryptophan (CAS No.
73-22-3), tyrosine (CAS No. 60-
18-4) and valine (CAS No. 72-18-4).
LIPIDS 3.9%:_ _soya oil (CAS No. 8001-22-7).
GLUCOSE 9.7%: glucose monohydrate (CAS No. 5996-10-1)
ELECTROLYTES 0.7%: calcium chloride dihydrate (CAS No. 10035-04-8),
magnesium sulfate
heptahydrate (CAS No. 10034-99-8), potassium chloride (CAS No.
7447-40-7), sodium acetate
trihydrate (CAS No. 6131-90-4) and sodium glycerophosphate (CAS No.
1334-74-3).
Kabiven G19% consists of a three chamber bag and an overpouch. An
oxygen absorber is placed
between the inner bag and the overpouch. The inner bag is separated
into three chambers by seals
which can be separated for mixing. The individual chambers contain
glucose, amino acid solutions,
and fat emulsion, respectively. The glucose and amino acid solutions
are clear solutions while the fat
emulsion is white.
Each bag contains the following different volumes depending on the
four pack sizes.
2566 mL
2053 mL
1540 mL
1026 mL
Glucose (19%)
1316 mL
1053 mL
790 mL
526 mL
Amino acids and electrolytes (_Vamin 18 Novum)_
750 mL
600 mL
450 mL
300 mL
Triglycerides (_Intralipid 20%)_
500 mL
400 mL
300 mL
200 mL
This corresponds to the following compositions.
Active Ingredients (g)
2566 mL
2053 mL
1540 mL
1026 mL
Soya Oil (g)
100
80
60
40
Glucose monohydrate
_Corresponding to Glucose (anhydrous)